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XENPOZYME (OLIPUDASE ALFA-RPCP)
XENPOZYME (generic name: OLIPUDASE ALFA-RPCP) is a drug developed by GENZYME CORP. It is currently FDA-approved for Niemann-Pick disease, type A, Niemann-Pick disease, type B.
At a glance
| Generic name | OLIPUDASE ALFA-RPCP |
|---|---|
| Sponsor | GENZYME CORP |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
- Niemann-Pick disease, type A
- Niemann-Pick disease, type B
Boxed warnings
- WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS Patients treated with XENPOZYME have experienced life-threatening hypersensitivity reactions, including anaphylaxis. Appropriate medical monitoring and support measures, including cardiopulmonary resuscitation equipment, should be readily available during XENPOZYME administration. If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue XENPOZYME immediately and initiate appropriate medical treatment. In patients with severe hypersensitivity reactions, a desensitization procedure to XENPOZYME may be considered [see Warnings and Precautions (5.1) ] . WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS See full prescribing information for complete boxed warning. Appropriate medical monitoring and support measures, including cardiopulmonary resuscitation equipment, should be readily available. If a severe hypersensitivity reaction occurs, discontinue XENPOZYME immediately and initiate appropriate medical treatment. ( 5.1 )
Common side effects
- Headache
- Cough
- Diarrhea
- Hypotension
- Ocular hyperemia
- Erythema
- Asthenia
- Pharyngitis
- Dyspnea
- Urticaria
- Papule
- Myalgia
Key clinical trials
- A Phase 2/3, Multicenter, Randomized, Double-blinded, Placebo-controlled, Repeat-dose Study to Evaluate the Efficacy, Safety, Pharmacodynamics, and Pharmacokinetics of Olipudase Alfa in Patients With (Phase 2)
- A Prospective Observational Study to Assess the Long-term Safety and Immunogenicity of Olipudase Alfa Therapy During Routine Clinical Care in Pediatric Patients Less Than 2 Years of Age With Acid Sphi (N/A)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- XENPOZYME CI brief — competitive landscape report
- XENPOZYME updates RSS · CI watch RSS
- GENZYME CORP portfolio CI
Frequently asked questions about XENPOZYME
What is XENPOZYME?
XENPOZYME (OLIPUDASE ALFA-RPCP) is a pharmaceutical drug developed by GENZYME CORP, indicated for Niemann-Pick disease, type A, Niemann-Pick disease, type B.
What is XENPOZYME used for?
XENPOZYME is indicated for Niemann-Pick disease, type A, Niemann-Pick disease, type B.
Who makes XENPOZYME?
XENPOZYME is developed and marketed by GENZYME CORP (see full GENZYME CORP pipeline at /company/genzyme-corp).
What is the generic name of XENPOZYME?
OLIPUDASE ALFA-RPCP is the generic (nonproprietary) name of XENPOZYME.
What development phase is XENPOZYME in?
XENPOZYME is FDA-approved (marketed).
What are the side effects of XENPOZYME?
Common side effects of XENPOZYME include Headache, Cough, Diarrhea, Hypotension, Ocular hyperemia, Erythema.
Related
- Manufacturer: GENZYME CORP — full pipeline
- Therapeutic area: All drugs in Other
- Indication: Drugs for Niemann-Pick disease, type A
- Indication: Drugs for Niemann-Pick disease, type B
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing